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Botox Deaths Lead to Calls for Black Box Warning

Jan 25, 2008 | Parker Waichman LLP Botox and Myobloc have been linked to 16 botulism deaths and more hospitalizations due to botulinum toxin spreading inside the bodies of those patients.  In response, Public Citizen, a U.S. consumer group, is calling for stronger warnings on the drugs following reports of the deaths.  Public Citizen asked U.S. authorities to require the strongest possible warning—the black box—to be included on Allergan Inc.'s Botox and Solstice Neurosciences Inc.'s Myobloc.  Botox is best known for smoothing facial wrinkles but is medically approved for treating cervical dystonia, or rigid neck muscles; Myobloc is only approved for the neck condition.  Both injections are made with forms of the botulinum toxin, which blocks nerve impulses to muscles, relaxing them.

Public Citizen said it reviewed 180 reports submitted to the Food and Drug Administration (FDA) by manufacturers involving patients injected with Botox or Myobloc.  Reports detailed cases of muscle weakness, difficulty swallowing, or aspiration pneumonia, a serious condition caused by breathing a foreign material into the lungs.  Reports to the FDA do not prove a product caused a particular problem, but the agency uses the reports to find patterns of potential complications.  "There are no safety issues raised in the petition that are not already addressed in the labeling for Botox," Allergan said, adding that it is in frequent dialogue with the FDA to ensure proper labeling and submits all information it receives on adverse events regardless of whether or not they are related to Botox.  Solstice Neurosciences reported it recently provided safety data to the FDA and stood behind the drug’s current prescribing information.

Of the cases reported to the FDA, 16 were fatal.  Of these, four involved children under 18.  There were also 87 patient hospitalizations linked to the medication.

Dr. Sidney Wolfe, director of Public Citizen's Health Research Group, said such problems could occur if botulinum toxin spreads from the injection site to places such as the esophagus, causing partial paralysis.  Instructions for Botox and Myobloc mention the issue but it is easy to miss, he said.

Public Citizen asked the FDA to order a black-box warning to highlight the concern, to draft a notice to doctors, and to require a consumer-friendly guide explaining the medicines’ risks to be distributed by doctors when administering the drugs.  "These significantly improved warnings to doctors and patients would increase the likelihood of earlier medical intervention when symptoms of adverse reactions to botulinum toxin first appear and could prevent more serious complications, including death," Public Citizen said in a petition to the FDA.

Early symptoms of botulinum toxin include dry mouth, difficulty breathing or swallowing, slurred speech, drooping eyelids, and muscle weakness.  The group said European regulators have warned physicians to watch for signs of botulinum toxin complications.  FDA spokeswoman Karen Riley said the agency would not comment while the Public Citizen petition was under review.

In November, Allergan projected worldwide sales for Botox would top $1.1 billion in 2007.  Allergan shares closed down 1.4 percent to $64.12 at the end of regular trading Thursday on the New York Stock Exchange.

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